CyPass Micro-Stent wins approval

The FDA has approved Alcon’s CyPass Micro-Stent, the second minimally invasive glaucoma surgical device approved for use in combination with cataract surgery.

Unlike other glaucoma surgical devices, CyPass does not access Schlemm’s canal or the conventional aqueous outflow pathway. CyPass was designed to create a permanent conduit from the anterior chamber to the suprachoroidal space, to drain the aqueous internally.

It is implanted into the supraciliary space through a clear corneal incision, technique that avoids formation of a filtering bleb and spares the conjunctiva. CyPass is intended to be used in combination with cataract surgery or as a stand-alone procedure for open-angle glaucoma.

A study including 505 patients showed that 72.5% of those treated with the CyPass micro-stent achieved significantly lower IOP compared with those who underwent surgery alone. The reductions were maintained throughout the 2-year follow-up period, with no significant difference in the complications between the CyPass and control groups (39.3% and 35.9%, respectively).

An earlier, single-arm study showed that the CyPass lowered IOP and precluded the need for invasive glaucoma surgery in 80% of participants, all of whom had previously failed medical treatment.